Mariner RDX MX2-000020

GUDID 10889981289829

Mariner RDX Locking Cap Loader 2

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: 10889981289829
• NIH Device Record Key: 9ba29a6a-7c72-4f44-a60f-af6523bedc7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mariner RDX
• Version Model Number: MX2-000020
• Catalog Number: MX2-000020
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981289829 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222110

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10889981289829]

Moist Heat or Steam Sterilization

[10889981289829]

Moist Heat or Steam Sterilization

[10889981289829]

Moist Heat or Steam Sterilization

[10889981289829]

Moist Heat or Steam Sterilization

[10889981289829]

Moist Heat or Steam Sterilization

[10889981289829]

Moist Heat or Steam Sterilization

[10889981289829]

Moist Heat or Steam Sterilization

[10889981289829]

Moist Heat or Steam Sterilization

[10889981289829]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-09-11
• Device Publish Date: 2023-01-06

On-Brand Devices [Mariner RDX]

• 10889981289874: Mariner RDX Tab Remover
• 10889981289867: Mariner RDX Reamer
• 10889981289744: Mariner RDX Locking Cap
• 10889981289829: Mariner RDX Locking Cap Loader 2